AB1782-HPR USABILITY AND ACCEPTABILITY OF A NEW AUTOINJECTOR DEVICE AND ITS ASSOCIATED APP IN RHEUMATOLOGY PATIENTS
Authors: R. Alten, G. Citera, M. Latymer, D. C. Gruben, H. Kameda
Journal: Annals of the Rheumatic Diseases (2023)

<h3>Background</h3> SMARTCLIC is a new reusable autoinjector with a dose-dispensing cartridge for subcutaneous self-administration of biotherapeutics for patients. The device can connect to the optional SmartClic mobile app to aid in tracking injections and other treatment or symptom data. <h3>Objectives</h3> The aim of this study was to assess patient opinion data on ease of use and usability of the SmartClic injector and app. <h3>Methods</h3> This study presents final data of all patients (N=264) from a global study. Patients from Argentina (n=50), Australia (n=15), Germany (n=46), France (n=28), Japan (n=75), and Spain (n=50), were included. After completing a patient profiling questionnaire, adult patients (≥18 years old) with rheumatoid arthritis (RA), psoriatic arthritis (PsA) or juvenile idiopathic arthritis (JIA), and prescribed an injectable biologic, each received training to use the device and cartridge and performed simulated injections. Participants completed a device evaluation questionnaire with including the following categories: 'ease of use' (14 questions), 'usability effectiveness' (11 questions), 'benefit of device features' (8 questions) and 'form factor' (7 questions). Participants also received a storyboard presentation summarizing key features of the optional app, which they could test on an Android/or iOS device, before completing up to 16 questions on connectivity and the app. Responses to device/and app questions were recorded as Likert scale ratings from 1 (extremely negative) to 7 (extremely positive). Estimates of patient training time for the device were also provided. Hand function based on the Functional Index of Hand Osteoarthritis Arthropathies (FIHOA) score, hand pain in the injection hand due to arthritis and grip strength were also recorded. Mean values are reported. The percentage of negative (Likert scale rating 1-2), neutral (3-5) and positive (6-7) responses for each category were determined. <h3>Results</h3> A total of 264 patients (mean age [range], 50 [18-85] years; 76% female) participated in the study. Patient diagnosis was, RA (71%), PsA (24%) and JIA (5%). The majority of patients (90%) were right-handed. While most patients (73%) always self-injected their medication, 19% of patients reported that they were mostly assisted with their injections or never self-inject. Most patients performed injection simulations using the dominant hand (77%) and chose the abdomen (54%), thigh (36%) or both (10%) abdomen and thigh as the injection site. Hand function based on the mean FIHOA score was 5.6 (range 0-24), and hand pain in the injection hand due to arthritis was 2.8 (range 1-7). Mean grip strength (range) was 19 (0-60) kg and 18 (2-54) kg in the dominant and non-dominant hand, respectively. Patients reported being "extremely comfortable" (58%) or "slightly comfortable" (35%) with digital equipment. Mean device evaluation scores (% positive responses) were: device ease of use 6.4 (87%), usability effectiveness 6.4 (87%), benefit of device features 6.6 (92%), form factor 6.2 (80%) and connectivity and app 6.2 (79%). The mean time (range) estimate for training a patient to effectively use the device and cartridge was 9.6 minutes (range 0-30 minutes). <h3>Conclusion</h3> Patients with RA, PsA or JIA, and experienced at receiving biologic treatment for their conditions, responded positively to the new autoinjector device and app across all categories. These features will contribute to a better experience of self-injection. <h3>Acknowledgements</h3> This study was sponsored by Pfizer. Medical writing support was provided by Andrea Schauenburg of Engage Scientific Solutions and funded by Pfizer. <h3>Disclosure of Interests</h3> Rieke Alten Consultant of: AbbVie, Bristol-Myers Squibb, Gilead, Lilly, Novartis, Pfizer and UCB, Grant/research support from: AbbVie, Bristol-Myers Squibb, Galapagos, Gilead, Janssen, Lilly and Pfizer, Gustavo Citera Consultant of: AbbVie, Amgen, BMS, Boehringer, Janssen, Lilly, Pfizer, Raffo, Sandoz, Grant/research support from: Boehringer, Janssen, Pfizer, Mark Latymer Shareholder of: Pfizer, Employee of: Pfizer, David C Gruben Shareholder of: Pfizer, Employee of: Pfizer, Hideto Kameda Speakers bureau: AbbVie, Asahi-Kasei, Bristol-Myers Squibb, Chugai, Eisai, Janssen, Lilly, Mitsubishi-Tanabe, Novartis and Pfizer, Consultant of: AbbVie, Bristol-Myers Squibb, Janssen, Lilly, Novartis, Sanofi and UCB, Grant/research support from: AbbVie, Asahi-Kasei, Boehringer Ingelheim, Chugai, Eisai, Mitsubishi-Tanabe, Pfizer and Taisho.